Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
Brainlab AG
1.2
In Commercial Distribution

  • 04056481145385 ()


  • Multidisciplinary medical image management software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing a Windows platform.
SPAULDING MEDICAL
3.0.6.1
In Commercial Distribution

  • B441SMWINCLIENTAPP0 ()
SMWINCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an IOS platform.
SPAULDING MEDICAL
1.3.6.1
In Commercial Distribution

  • B441SMIOSCLIENTAPP0 ()
SMIOSCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Spaulding Client Application is a web based application for trained users of the Spaulding Medical Electrocardiograph device 2100iQ. The application enables clinicians or trained core personnel who are acting on the orders of a licensed physician to process, display, store, and print diagnostic 12 lead ECGs utilizing an Android platform.
SPAULDING MEDICAL
1.2.6.1
In Commercial Distribution

  • B441SMANDCLIENTAPP0 ()
SMANDCLIENTAPP

  • Electrocardiographic long-term ambulatory recording analyser application software
Optionally, the electrostimulator (SPM01M1) can require the combined use with the MySPM@Home mobile application, as accessory of the Subject device. It allows to monitor the user and guide rehabilitation and training through specific protocols.
NCS LAB SRL
SPM01A2
In Commercial Distribution

  • 08051122040933 ()
SPM01A2

  • Physical therapy transcutaneous neuromuscular electrical stimulation system
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649293 ()


  • Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00190199649286 ()


  • Cardiopulmonary physiological parameter analysis software
A mobile companion app for Bose® Hear products
BOSE CORPORATION
865924-0010
Not in Commercial Distribution

  • 00017817831918 ()


  • Air-conduction hearing aid, receiver-in-canal
No Description
ECENTIAL ROBOTICS
L60018
In Commercial Distribution

  • 03701311501497 ()


  • Robotic surgical navigation system application software
iOS version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078962 ()
P1646054

  • Audiometric/hearing device software
Android version of the Baha Smart App
Cochlear Bone Anchored Solutions AB
V 1.2
In Commercial Distribution

  • 09321502078955 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646035
In Commercial Distribution

  • 09321502053006 ()
P1646035

  • Audiometric/hearing device software
No Description
Cochlear Bone Anchored Solutions AB
P1646054
In Commercial Distribution

  • 09321502052993 ()
P1646054

  • Audiometric/hearing device software
DreamMapper iOS NA Instance v 2.13
Respironics, Inc.
2.13
In Commercial Distribution

  • 00606959051331 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.11
Respironics, Inc.
2.11
In Commercial Distribution

  • 00606959049932 ()
1101478

  • Self-care monitoring/reporting software
DreamMapper iOS NA Instance v 2.10
Respironics, Inc.
2.10
In Commercial Distribution

  • 00606959049086 ()
1101478

  • Self-care monitoring/reporting software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
2.0
In Commercial Distribution

  • D16420251 ()


  • CAD/CAM software
The Progressive Orthodontics App is an orthodontic appliance design and treatment simulation software. This software is for use by dental professionals in a healthcare facility to assist in diagnosis and design solutions for patients. Digital scans (3D) of a patient’s dentition can be loaded into the software and the dental professional can then review different treatment plans and simulations for each individual patient and decide on the most appropriate treatment.
PROGRESSIVE AMERICA, INC.
0.9.6
In Commercial Distribution

  • D16409625 ()


  • CAD/CAM software
No Description
Thought Technology Ltd.
SA9030
In Commercial Distribution

  • 07540191000586 ()


  • Psychophysiological biofeedback system
  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Perineal orifice incontinence-control electrical stimulation system probe, reusable
No Description
Thought Technology Ltd.
SA9013
In Commercial Distribution

  • 07540191000548 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
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